Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

Haemophilus Influenzae Type b Clinical Trial

Official title:

A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808392
• Other study ID #: M37P2
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2008
• Last updated: December 26, 2011
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 916
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 4 Months

Eligibility

Inclusion Criteria:

• Infants of either sex, aged 2 - 4 months

• In good health as determined by:

• medical history

• physical examination

• clinical judgment of the investigator;

• Available for all visits scheduled in the study and able to comply with all study regulations

• For whom written informed consent has been obtained from at least one parent or legal guardian

Exclusion Criteria:

• Parent or legal guardian is unwilling or unable to give written informed consent to participate in study

• Infants who have received any other Haemophilus influenzae type b immunization dose before

• Infants who presented a previous disease potentially related to Haemophilus influenzae type b

• Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease

• Premature (before 37th week of gestation) or birth weight less than 2500 g

• History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component

• Fever = 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment

• Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease

• Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder

• Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder

• Subjects with a clinically significant genetic anomaly

• Treatment with corticosteroids or other immunosuppressive drugs

• Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives

• Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.

• Participation in any other investigational trial simultaneously

• Planned surgery during the study period

• Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b
• Influenza, Human

Intervention

Biological:
• Haemophilus influenzae type b vaccine
3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
• Commercial Haemophilus influenzae type b vaccine
3 doses one month apart of Haemophilus influenzae type b vaccine.

Locations

Country	Name	City	State
China	the CDC of Dingxing county(site no 02)	Dingxing	Hebei
China	The CDC of Zhengding county(site no 01)	Zhengding	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).		90 days	No
Secondary	Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.		90 days	Yes